11+ ISO 13485 Jobs in Pune | ISO 13485 Job openings in Pune

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

Responsibilities:

•Design, develop, and implement integration solutions using Oracle Integration Cloud (OIC).

•Collaborate with business analysts and stakeholders to understand integration requirements and translate them into technical specifications.

•Develop and maintain integration interfaces between various on-premises and cloud applications.

•Troubleshoot and resolve integration issues in a timely manner.

•Perform unit testing and support user acceptance testing (UAT) to ensure high-quality deliverables.

•Document integration processes, configurations, and best practices.

Qualifications:

• Proven experience as an Oracle Integration Cloud Developer or similar role.

• Strong knowledge of Oracle Integration Cloud (OIC) components and capabilities.

• Proficiency in designing and developing integrations using OIC, including REST and SOAP APIs, file-based integrations, and orchestration.

• Experience in PLSQL, working with Datahub concept is highly preferable.

• Strong understanding of HCM Extracts and BI Publisher.

• Experience working with various authentication mechanisms, protecting data at rest and data in transit.

• Familiarity with integration patterns, data mapping, and transformation techniques.

• Familiarity with CI/CD pipeline and Git for version control

• Strong communication and collaboration skills.

Preferred Qualifications:

• 4 plus years of Oracle Integration Cloud certification.

• Experience with other integration platforms and tools.

•Knowledge of Oracle ERP Cloud, HCM Cloud, EPM or other Oracle applications.

Job description:

Job description

Qualification : Pharmacy or BSc Plain or any medical background preferred

Freshers are Eligible

a. Will be responsible for

resolution of queries

received through calls for all

queries present in the

question bank

b. Will be responsible for

validation of records

If call is not reachable then do whatsapp call

Job Types: Full-time, Fresher

Benefits:

• Health insurance
• Provident Fund

Ability to commute/relocate:

• Pune, Maharashtra: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Work Location: In person

Sr. Product Manager at OneCard 

At Onecard, we're re-imagining the credit card for a new generation of users. Product development is an extremely collaborative effort between engineering, design, and customer-facing teams. You’d be joining a small team of experienced Product Managers who have helped build successful products at companies such as Gaana, Walnut, ICICI Bank among others. 

YOU MAY BE A GOOD FIT IF:

• You can think in terms of the big picture, but deliver on the details
• You observe users and talk to them to get insights for building products. 
• You have a nose for great products, and advocate for new features with qualitative and quantitative reasoning
• You do whatever it takes to make your product and team successful, whether that means writing a QA plan or hunting down the root cause of a user’s frustration. This is very important as we're rapidly growing. 
• You can turn incomplete, conflicting, or ambiguous inputs into solid action plans
• You communicate with empathy and exceptional precision
• You are technical enough to ask engineers good questions about architecture and product decisions alike
• Beyond just shipping new products, you obsess about continuous product improvement

REQUIREMENTS

• You’ve spent at least 3 years in product management, especially working on mobile apps. 
• You’ve built something with 100k+ users in a consumer facing application. If you've built something on your own - a blog or a website, please send us a link. 
• You’ve worked with design teams and software like Figma/Zeplin/Balsamiq. 
• Experience in Fintech and gaming is preferred. Especially working on reward programs. 

You’ve built something with 100k+ users in a consumer facing application. If you've built something on your own - a blog or a website, please send us a link. 

YOU SHOULD INCLUDE THESE IN YOUR APPLICATION:

A few words on...

• Why you’re interested in being a product manager at OneCard in particular
• The product you are most proud of shipping, and your role in its development
• The biggest product mistake you’ve made (we all have them!)

• Create and lead innovative programs, software, and analytics that drive improvements to the availability, scalability, efficiency, and latency of the application
• Work with Directors to define and execute technical strategy and arbitrate technical processes and decisions.
• Work with development teams to guide future technology choices and foster cross-team collaboration
• Work across all teams to help define and clarify requirements, explore technical feasibility, and help define product directions and plans.
• Work closely with product & engineering leaders and tech leads to turn requirements into actionable plans that teams can understand.
• Define, Refine & Develop POCs in quick turnaround time and demonstrate the same to all stakeholders effortlessly
• Embed with teams from time to time to write code, provide technical guidance, etc.
• Very deep knowledge of the entire tech stack. Excellent understanding of the entire SDLC.
• Provides a multiplier effect in getting stuff done.
• Acts as SME for the team or product area within the Engineering organization and for cross-functional organizations as well.
• Teaches others why new features are important. Good understanding of customer use cases.

• A Bachelor's degree in any technical discipline
• Minimum 5 years of experience administering AEM applications
• Build management using Bamboo/Jenkins or relevant tech
• Configuration and Release management
• Design and build enablement
• Good communication skills

Designation: Kafka Consultant

Job Description:

• 3-8+ years of experience programming in a backend language (Java / Python), with a good understanding of troubleshooting errors.
• 5+ years of experience in Confluent Kafka / 3+ years of experience in Confluent Kafka
• Cloud Kafka, Control Central, Rest Proxy, HA Proxy, Confluent Kafka Connect, Confluent Kafka Security features
• 3-5+ years of working experience with different databases such as Oracle/Mysql/MongoDB/Snowflake/RDS databases.
• 3-5+ years of experience with AWS/GCP/Azure preferred AWS. AWS Solutions Architect certifications are preferred.
• 2+ years of experience with Monitoring tools (Prometheus, Grafana / Spl
• Proficient in building/scaling large systems end to end using Tibco BW5, BW6 or other high-performance languages,
• developer tools, CI/CD, DevOps, GitHub, Terraform, and Ansible.

• Answer Inbound/Outbound Calls Professionally, Explain Products And Services To Customers
• Identify Customer's Needs And Wants And Convince Them To Buy The Product/Service
• Gain Comprehensive Product Knowledge To Enhance Performance
• International Voice Process/International BPO
• U.K. Shift Timings - 01:30 PM - 11:30 PM
• Fluent Communication Skills Mandatory
• Location - N.I.B.M. Kondhwa, Pune M.H.